Politico | Flood of Products Containing Marijuana Extract puts FDA in a Bind

Marc Scheineson is quoted on the cases that may historically alter the scope of authority for the Food and Drug Administration and the Centers for Medicare & Medicaid Services.

This week, CMS issued a proposed rule to implement policies in the Medicaid Drug Rebate Program (MDRP) and CBO released health insurance coverage projections for 2023 to 2033.

Marc Scheineson is quoted on the timing for getting the Food and Drug Administration’s user fee reauthorization package to President Biden’s desk before Congress leaves for summer recess.

Marc Scheineson is quoted on Robert Califf’s nomination to head the U.S. Food and Drug Administration.

Alston & Bird has expanded its health care and life sciences regulatory and compliance capabilities with the addition of counsel Alexandra Marzelli, former associate chief counsel at the U.S. Food and Drug Administration (FDA). Based in the firm’s Washington, D.C. office, Marzelli joins Alston & Bird’s Health Care and FDA/Food, Drug & Device Groups, where she will advise clients on the FDA’s complex approval process and regulatory compliance for prescription and over-the-counter drugs, biologics, medical devices, food ingredients, and other products regulated by the agency.